Pacemaker Lead Connector

Name: Pacemaker Lead Connector | Cardiac Lead Interface Connector - Frigate
Price: 249.00 USD
Availability: InStock

The Pacemaker Lead Connector plays a critical role in maintaining stable electrical contact between the pulse generator and endocardial lead system, even under long-term physiological stress. It features multilayered conductive surfaces and precision-engineered spring geometries that apply consistent radial pressure, minimizing contact resistance fluctuations and reducing the risk of fretting and signal dropout over millions of cardiac cycles.

Material Specification

MP35N (ASTM F562), Platinum-Iridium (90/10, ASTM F1058), Titanium 6Al-4V ELI (ASTM F136)

Dimensional Tolerance

±0.01mm (Critical Features), ±0.025mm (Overall Profile), Concentricity ≤0.005mm

Surface Finish Requirements

Ra ≤0.2µm (Contact Surfaces), Ra ≤0.4µm (Non-Critical), Electropolished (Per ASTM B912)

Certifications & Standards

ISO 13485, FDA 510(k), ISO 5841-3 (Cardiac Leads), IEC 60601-1 (Electrical Safety)

Electrical Conductivity

Resistivity ≤1.5 µΩ·m (MP35N), Contact Resistance ≤50mΩ, EMI Shielding (MIL-STD-461)

Product Description

To ensure signal fidelity, the connector system also integrates controlled impedance pathways and specialized shielding. This design effectively suppresses electromagnetic noise within the subcutaneous routing environment, preserving signal integrity and reliable pacing performance throughout the device’s lifespan.

Thread & Fitment

IS-1/DF-1/IS-4 Standards, Thread Pitch – 0.5mm±0.02mm, Taper Fit – 3°±0.1°

Corrosion Resistance

ASTM F2129 (Pitting Resistance), Salt Spray 1000hrs (ASTM B117), Zero Crevice Corrosion

Mechanical Strength

Tensile Strength ≥1000MPa, Fatigue Life – 10⁸ Cycles @ 1N Load, Torque Resistance ≥0.5N·m

Cleanliness

Particle Count ≤5mg/kg (ISO 19227), Endotoxin <0.5 EU/mL (USP ), IPA Cleanroom Wipedown

Inspection & Testing

100% CMM (±0.005mm), Metallography (ASTM E3), Helium Leak Test (<1×10⁻⁹ cc/sec)

Technical Advantages

Pacemaker Lead Connector addresses mechanical instability caused by differential tissue movement, thoracic expansion, and patient mobility. Connector housings and contact interfaces are micro-machined to sub-10 micron tolerances, ensuring rigid coupling that resists micro-gap formation. The system integrates elastoplastic buffering zones to distribute axial and torsional stresses away from the lead fixation points, minimizing strain-induced degradation and preventing interface microcracking over time.

Pacemaker Lead Connector utilizes corrosion-resistant alloys such as MP35N, platinum-iridium, and anodized titanium in contact and housing elements, selected for electrochemical stability under continuous exposure to ionic body fluids. The contact surfaces undergo passivation and proprietary coatings that inhibit galvanic interaction with lead terminals, ensuring predictable electrical behavior across implant lifetimes exceeding 10 years. Material selection is validated under accelerated aging and simulated biofluid immersion protocols to confirm longevity.

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Industry Applications

Implantable Cardiac Pacemakers

Pacemaker Lead Connector provides stable electrical interface between pulse generator and endocardial leads for long-term atrial and ventricular pacing applications.

Cardiac Resynchronization Therapy Devices

Pacemaker Lead Connector supports multi-lead synchronization by enabling low-impedance connections in bi-ventricular and tri-ventricular pacing systems.

Implantable Cardioverter-Defibrillators (ICDs)

Pacemaker Lead Connector ensures high-voltage delivery paths and sensing channel isolation for defibrillation and anti-tachycardia pacing in ICD systems.

Temporary Transvenous Pacing Systems

Pacemaker Lead Connector facilitates rapid lead exchange and reliable temporary pacing signal conduction during acute arrhythmia or surgical procedures.

Lead Extension Interfaces

Pacemaker Lead Connector enables precise signal transmission across modular extensions for repositioning or bridging in complex cardiac anatomies.

MRI-Compatible Pacemaker Systems

Pacemaker Lead Connector maintains electromagnetic compatibility by minimizing RF heating and preventing eddy current formation in MRI conditional systems.

Interface Standardization with Multi-Lead System Compatibility

Pacemaker Lead Connector is engineered to comply with IS-1, IS-4, DF-4, and other recognized lead interface standards, enabling seamless integration with multi-electrode pacing and defibrillation systems. The connector platform accommodates high-density pin layouts without compromising mechanical robustness or increasing insertion force beyond the clinical handling threshold.

Pacemaker Lead Connector undergoes fatigue testing under simulated multi-axial loading profiles to replicate cardiac pulsation, respiratory motion, and arm displacement. Internal crimp and spring elements are engineered to withstand >10^7 load cycles without electrical discontinuity, deformation, or mechanical decoupling.

Having Doubts? Our FAQ

Check all our Frequently Asked Question

How does Frigate ensure the electrical reliability of Pacemaker Lead Connectors under dynamic physiological conditions?

Frigate designs Pacemaker Lead Connectors with precision-engineered spring contacts that pflegen consistent pressure against lead terminals, ensuring low and stable contact resistance. The connectors undergo rigorous fatigue and vibration testing simulating millions of cardiac cycles to validate mechanical and electrical stability. Frigate also employs advanced conductive coatings to minimize signal degradation over time. This approach reduces the risk of intermittent pacing failures caused by micro-movements in vivo.

What materials does Frigate use in Pacemaker Lead Connectors to optimize biocompatibility and corrosion resistance?

Frigate utilizes high-performance alloys such as MP35N, platinum-iridium, and titanium for contact and housing components due to their excellent electrochemical stability. These materials are carefully selected to prevent corrosion and galvanic reactions in the ionic body environment. Frigate’s manufacturing processes include surface passivation and biocompatibility testing per ISO 10993 standards. This ensures the connectors remain inert and safe throughout extended implant durations.

How does Frigate manage sealing and fluid ingress prevention in Pacemaker Lead Connectors?

Frigate employs multi-layer sealing strategies involving silicone gaskets and overmolded polymer barriers to achieve hermetic sealing. Each Pacemaker Lead Connector undergoes helium leak and hydrostatic pressure testing to verify seal integrity under simulated implant conditions. The connectors are designed to eliminate micro-channels that could allow fluid intrusion. This robust sealing prevents corrosion and electrical failure caused by moisture ingress.

How does Frigate support multi-lead system compatibility with Pacemaker Lead Connectors?

Frigate manufactures Pacemaker Lead Connectors compliant with established standards like IS-1, IS-4, and DF-4, enabling seamless integration with various pacing and defibrillation leads. Connector geometries pflegen tight dimensional tolerances to ensure reliable mating and minimize insertion forces. Frigate’s engineering teams also offer customization for hybrid or legacy lead formats. This versatility supports OEM requirements for diverse device platforms.

What quality controls does Frigate implement during Pacemaker Lead Connector production?

Fregatte operates under ISO 13485 certified quality management systems with full traceability of materials and processes. Each connector batch undergoes electrical resistance measurement, dimensional inspection, and mechanical force testing to meet stringent specifications. Post-assembly, 100% functional testing confirms electrical continuity and mechanical robustness. Documentation is provided to support regulatory submissions and ensure compliance with medical device standards.

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